Job description :
We are seeking a Senior Quality Engineer to support process development, manufacturing quality, and compliance for implantable cardiac and neuromodulation medical devices.
This role focuses on inspection optimization, process and test method validation, and continuous improvement within a regulated medical device manufacturing environment.
Roles & Responsibilities:
Lead Inspection Optimization projects (manual, automated, and semi-automated inspection)
Support equipment development, IQ/OQ/PQ, process characterization, and validation
Develop and execute Test Method Validation (TMV), including Gage R&R / MSA
Ensure compliance with FDA, ISO, and GMP quality requirements
Support CAPA, nonconformance investigations, change control, and risk management (pFMEA/dFMEA)
Drive quality metrics, scorecards, and continuous improvement initiative...